AASAP: a program to increase recruitment and retention in clinical trials

Patient Educ Couns. 2012 Mar;86(3):372-7. doi: 10.1016/j.pec.2011.07.002. Epub 2011 Aug 9.


Objective: To evaluate a theory based, subject-centered, staff/subject communication program, AASAP (anticipate, acknowledge, standardize, accept, plan), to increase recruitment and retention in RCTs.

Methods: AASAP was evaluated with logistical regression by comparing rates of recruitment (at telephone screening, baseline assessment, initial intervention) and intervention retention (over 16 weeks) before (-AASAP) and after (+AASAP) it was introduced to a 3-arm RCT to reduce disease distress among highly distressed subjects with type 2 diabetes.

Results: Included were 250 subjects in -AASAP and 338 in +AASAP. Significant improvement in recruitment occurred at each of the 3 recruitment stages: agreed at screening (OR=2.52; p<0.001), attended baseline assessment (OR=1.91; p<0.001), attended initial intervention (OR=1.46; p<0.03). Higher education and shorter diabetes duration predicted better recruitment in -AASAP (OR=2.23; p<0.001), but not in +AASAP. AASAP also improved intervention retention over 16 weeks (OR=3.46; p<0.05).

Conclusion: AASAP is a structured program of subject/staff communication that helps improve external validity by enhancing both subject recruitment and retention.

Practical implications: AASAP can be taught to non-professional staff and can be adapted to a variety of health settings. It can also be used by clinicians to engage patients in programs of ongoing care.

Publication types

  • Evaluation Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Aged, 80 and over
  • Behavior Therapy
  • Communication
  • Diabetes Mellitus, Type 2 / psychology*
  • Diabetes Mellitus, Type 2 / therapy
  • Educational Status
  • Female
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Patient Compliance / psychology
  • Patient Dropouts / psychology
  • Patient Selection*
  • Patient-Centered Care
  • Professional-Patient Relations
  • Randomized Controlled Trials as Topic*
  • Stress, Psychological
  • Telephone